Remote Lead Clinical Study Manager: Strategy & Execution

Takeda; Boston (MA); On-site; USD 116,000 - 182,270; Full time

Job summary

Takeda is seeking a Lead Clinical Study Manager for a remote role reporting to the Clinical Operations Leadership team. The position focuses on leading study strategies, overseeing execution, and managing budgets across assigned programs.

Ideal candidates have 6+ years in pharma/ CRO with study management experience and fluent business English. The role includes collaboration with partners, vendor oversight, and ensuring regulatory compliance within Takeda SOPs.

Qualifications

• BS/BA in health-related, life science, or technology fields or equivalent.
• Advanced degree may supplement experience.
• 6+ years in pharma/ CRO with 4+ years study management oversight.
• Fluent business English, excellent communication skills.

Responsibilities

• Lead study operational strategy and planning for assigned programs.
• Oversee study execution to meet quality, schedule, and budget.
• Manage budgets, enrollments, and vendor performance.
• Collaborate with CROs/Strategic Partners and internal stakeholders.
• Ensure studies are inspection-ready and compliant with ICH GCP.

Skills

Clinical operations

Budget management

Vendor management

ICH GCP

Education

BS/BA in health-related or life sciences

Advanced degree considered beneficial

Job description

Takeda is seeking a Lead Clinical Study Manager for a remote role reporting to the Clinical Operations Leadership team. The position focuses on leading study strategies, overseeing execution, and managing budgets across assigned programs.

Ideal candidates have 6+ years in pharma/ CRO with study management experience and fluent business English. The role includes collaboration with partners, vendor oversight, and ensuring regulatory compliance within Takeda SOPs.